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Incorporating Mass Spectrometry into Biologic QC Control Environments for O-Glycan Analysis

Incorporating Mass Spectrometry into Biologic QC Control Env...

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第六届生物技术药物理化特性分析与质量研究技术研讨会

作者： Mark Hilliard Ciara A.McManus William Alley Ying Qing Yu john gebler Pauline M Rudd NIBRT Foster AvenueMount MerrionBlackrockCo Dublin Waters Corporation

O-linked glycans are typically more challenging to analyze than N-linked glycans,partly because of the diversity of the core structures as well as the lack of a universal ***,most O-glycan workflows are performed on high-end mass spectrometry instruments which are not available in most QC *** MS instruments do not provide the quantitative data required by the regulators and there can be a lack of skilled personnel to operate *** the emergence of O-glycosylated biotherapeutics,it is now necessary to develop alternative workflows;first a more research focused LC-QTof approach and secondly,a more QC compatible methodology employing a novel mass detector,the *** typically employ chemical techniques for O-linked glycan *** we present a microwave-assisted O-linked glycan release workflow that can be completed within 12-70 minutes in comparison to traditional beta-elimination methods which takes around 16 *** addition of the QDa mass detector allowed for the addition of mass data that is complementary to more traditional optical detectors that are found within the QC ***,we can increase MS sensitivity with the addition of an MS compatible fluorophore which also facilitates the collection of qualitative and quantitative LC-MS data which is not generally represented in current *** more complex samples or where accurate mass and MS/MS data is required,our LC-MS method can be transferred effortlessly to more research orientated instruments such as the QTof-MS.

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